K232656 is an FDA 510(k) clearance for the BLU TOTALE (Model: ENEOB852). This device is classified as a Over-the-counter Powered Light Based Laser For Acne (Class II - Special Controls, product code OLP).
Submitted by Premier North America, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on November 14, 2023, 75 days after receiving the submission on August 31, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris..
| 510(k) Number | K232656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2023 |
| Decision Date | November 14, 2023 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OLP - Over-the-counter Powered Light Based Laser For Acne |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris. |